DEKRA Certification B.V.

2drs. G.J. Zoetbrood

eing. A.A.M. Laan

Managing Director Certification Manager

© Integral publication of this certificate and adjoining reports is allowed

DEKRA Certification B.V. Meander 1051, 6825 MJ Arnhem P.O. Box 5185, 6802 ED Arnhem, The Netherlands

T +31 88 96 83000 F +31 88 96 83100 www.dekra-certification.com Company registration 09085396

CERTIFICATENumber: 2175799

The management system of:

PLAN 1 HEALTH S.R.L.Via Solari 533020 Amaro (UD)Italy

including the implementation meets the requirements of the standard:

CAN/CSA ISO 13485:2016Scope:Design and development, production of drug delivery devices, introducer sets and associated accessories

Certificate expiry date: 31 December 2018Certificate effective date: 4 July 2018Certified since: 21 May 2015